The purpose of this study is to survey tactile kinesthetic stimulation massage effects on growth (weight, height, head circumference) is healthy infants. 70 infants will be considered they are classified randomly into two groups exprimental (35 infants) and control (35 infants). Mothers completed the demographic questionnaire. This method In the experimental group will be done twise every day and each time for 15 minuty, for 4 continuous weeks. The first and third five minutes is for Tactile which is includes top-down and rotational movements on the abdomen. The second 5 minute, Kinesthetic Stimulation that involves Leges adduction and abduction and Bicycle movements at the same time same time.The control group will receive any intervention in the same period. Two groups infants been, one day,term and healthy and eat only breast milk. Weight, height and head circumference of the infants measured at birth time, the end of 14th day and the end of 28th day. In the end, are compared both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608228348N35
Registration date:2016-10-16, 1395/07/25
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-16, 1395/07/25
Registrant information
Name
Neda Mirbagher
Name of organization / entity
Kashan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 36 1555 0021
Email address
mirbagher_n@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Kashan University of Medical Sciences
Expected recruitment start date
2015-04-21, 1394/02/01
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of TKS (Tactile Kinesthetic Stimulation) massage on physical growth of healthy infants
Public title
The effect of massage on physical growth of infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: the one day infants weighing 4000-2500 grams, singleton, normal delivery, natural activity, appearance and color, the ability of breastfeeding, Apgar score above 7, no fetal malformations, Biographies after birth is normal, is terms, infant reflux is not severe.
Exclusion criteria: blood transfusions, Incidence acute physical problems , changing dietary habits in infantes during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using stratified random sampling
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan University of Medical Sciences
Street address
Kashan, Ravand Street, Kashan University of Medical Sciences
City
Kashan
Postal code
8715981151
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.KAUMS.REC.1394.117
Health conditions studied
1
Description of health condition studied
massage
ICD-10 code
Z50
ICD-10 code description
Care involving use of rehabilitation procedures
Primary outcomes
1
Description
Weight
Timepoint
Before intervention, after 2 weeks, after 4 weeks
Method of measurement
Balance grams
Secondary outcomes
1
Description
Height and head circumference
Timepoint
Before intervention,after 2 weeks, after 4 weeks
Method of measurement
In centimeter using a tape measure
Intervention groups
1
Description
Intervention group : Massage will be done twise every day and each time for 15 minuty, for 4 continuous weeks. The first and third five minutes is for Tactile Stimulation on the abdomen. The second 5 minute, kinesthetic Stimulation in leges.
Category
Prevention
2
Description
Control group: The control group will receive any intervention in the same period.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashan beheshti and Shabihkhani hospital maternity ward
Full name of responsible person
Neda Mirbagher
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences
Full name of responsible person
Dr hamidi
Street address
Ravand,Parastar Street , Kashan University of Medical sciences
City
Kashan
Grant name
_
Grant code / Reference number
_
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Kashan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 36 1555 6633
Email
salam_20012003@yahoo.co.ukmirbagher_n@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Kashan
Postal code
8715981151
Phone
+98 31 5554 0021
Fax
+98 36 1555 6633
Email
salam_20012003@yahoo.co.ukmirbagher_n@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Neda Mirbagher
Position
Ms
Other areas of specialty/work
Street address
Ravand,Parastar Street, Kashan University of Medical sciences
City
Postal code
8715981151
Phone
+98 36 1555 0021
Fax
+98 36 1555 6633
Email
salam_20012003@yahoo.co.ukmirbagher_n@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)